USPTO Patents Application 09870801

Jury Trial - Volume E

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Tuesday, May 6, 2003

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- VOLUME E -
IN THE UJHTEO STATES DISTRICT COURT
IH AHO FOR THE DISTRICT CT DELAWARE

P*qe 759

ARTHROCARE CORPORATION,
Plaintiff

vs .

SMITH 1 NEPHEW, INC. ,
Defendant

CIVIL ACTIOM

NO. 01-504 (SLR)

Hilralr.g>on, Delaware
Tuesday, Kay 6, 2003
9:30 o'clock, *.ct.

BEFORE: HONORABLE SUE L. ROBINSON, Chief Judge, and a jury

APPEARANCES:

MORRIS, NICHOLS, ARSHT & TUNNELL
BY: JACK B. BLUMENFELO, ESQ. and
KAREN JACOBS LOUDEN, ESQ.

-and-

Ofriciai Court Reporters

Page 761

PROCEEDINGS

(Proceedings commenced in the courtroom,
beginning at 9:30 a.m., and the following occurred without
the presence of the jury.)

THE COURT: Are there any issues before we bring
our jury in.

10 MR. MacFERRiN: Opposing counsel has some

1 objections to some of the exhibits we intend to use with

12 the witness and also to some deposition testimony we

13 intend to read to the jury.
MS. LOUDEN: I believe as to the evidence that

15 Smith & Nephew said it will introduce this morning, there

16 are two outstanding issues.
One is the use of certain demonstrative

18 exhibits, which we have objected to.

19 There is a couple of slides, but they fall in

20 the same category.
The first relates to Claim 1 of '882, which

22 your Honor will recall is subject to the certificate of

23 correction. Smith & Nephew's experts have offered no

24 opinion about whether the claim is invalid or not Yet
25. they purport to have some slides which show the claim as

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APPEARANCES (Continued):

WEIL, GOTSHAL i MANGES
BY: JARED BOBROW. ESQ,
TIMOTHY DeMASL ESQ. and
PERRY JL CLARK. ESQ.
(Redwood Shores, California)

Counsel for Plaintiff

FISH A RICHARDSON P C

BY: WILLIAM J. MARSDEN, JSL, ESQ,
KEITH A. WALTER. ESQ. and
EUGENE B. IOSW1GK. ESQ.

-and*

FISH A RICHARDSON
BY: MARK I HEBERT, ESQ,
(Boston, Massachusetts)

-and-

FISH A RICHARSON

BY: KURTS D. MacFERRIN, ESQ. and

KAREN L BOYD. ESQ.

(Redwood dry, California)

Counsel for Defendant

Page 760

Page 762

1 if it is not the corrected claim with its crossouts and
changes.

So we object to it both in terms of it being
outside of the expert report as well as being argumentative
and portraying the claim of something other than what it is
right now.

The second kind of objection which applies to

8 two or three of Smith & Nephew's exhibits, which I

9 understand they intend to use with fact witnesses — perhaps

10 they could clarify but, in any event, they have a number

11 of slides - we have no objection to the picture. For

12 example, this is a picture here of the Smith & Nephew

13 system. But they have argumentative headings, like the

14 fluid supply is not part of the ElectroBlade system.

15 Lawyer argument, of course, is not evidence.

16 We don't think they should be able to put up a demonstrative

17 that makes their arguments while they are examining 4

18 witnesses.

19 We can just deal with the demonstratives or I

20 can move to the deposition designations as well.

21 the COURT: No. Let's get done with the

22 demonstratives first.

23 The ones on the asserted claims of the '882

24 patent, I am not so troubled by the exhibit itself as the

25 fact that it's outside the scope of the expert's report.

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

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Page 875

Q. Okay. I'd like to finally go back to the SWOT
analysis and just be sure that we understand and you make
clear to us whose perspective the SWOT analysis is done
fc from.

MR. MR. HEBERT: SO if we Could get PX-343,

please... And it would be Page 48 within the document.
BY MR. HEBERT:

Q. You were shown this page in cross-examination, Mr.
10 Sparks. The SWOT analysis begins at the bottom of the
1 1 1 page and it's for ArthroCare; right?
A. Yes, that is correct

Q. Okay. From whose perspective is a SWOT analysis
supposed to be written from?
A. Again, as I said earlier, you put yourself into the
1 16 shoes, if you will, of the other company and think about
1 7 their business as they would, so that you're looking at
J 1 8 it from the inside out and making determinations about

1 19 what strength, weaknesses, opportunities and threats exist.

120 Q. Would it be fair to say that in doing a SWOT analysis,
|2I you are pretending to be the other company and thinking

1 22 about how they would view the world?

1 23 MR. BLUMENFELD: objection, leading.
24 THE COURT: Overruled.

125 THE WITNESS: Yes. The answer to the question

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THE witness: Thank you, your Honor.
Thank you, folks.

(Witness excused)

Page 877

MR. MacFERRiN: Good afternoon. My name is
Kurtis MacFerrin. I'm one of the attorneys representing
Smith & Nephew. And I will be calling Dr. Kim Manwaring
as Smith & Nephew's next witness. Dr. Manwaring will
testify about his opinion that certain claims in the '882
patent are invalid

Your Honor, for its next witness, Smith & Nephew
calls Dr. Manwaring.

THE COURT: All right. I think we'll have to
speak into the microphone a little bit more.

MR. MacFERRiN: All right I will, your Honor.

THE COURT: Thank you.

MR. HEBERT; Your Honor, if I might tidy up...

Julie, if you can assist...

A VOICE: Yes.

MR. HEBERT: I'll help.

... DR. KJM MANWARING, having
been duly sworn as a witness, was
examined and testified as follows ....

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Page 876

1 is you are putting yourselves in their shoes, as I said, so

2 you are pretending you are ArthroCare or Johnson & Johnson
or Olympus or Mitek or whomever.
BY MR. HEBERT:

Q. And what is the purpose of doing that, of pretending
you are the other company?

A. It eliminates — it makes it more objective and less

8 subjective. So if you do it and you use your own biases

9 and opinions, then you will miss what is a strength or a
10 weakness or opportunity or threat so you avoid doing that

And that's the reason why you pretend to be the other

12 company, so that you make sure you touch everything that

13 needs to be looked at, ultimately to figure out what their
strategy might be. You're guessing at their strategy.

15 Q. Why would you want to try to figure out what the

1 6 strategy of a competitor might be?
A. It's all about anticipation. Our goal as an
organization is to always be the most technologically
advanced in every area we operate in so you are using that
as an opportunity to anticipate how they may act and,
therefore, make sure that your own strategy is not one

J 22 that is going to lead you down the wrong path.

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MR. HEBERT: Nothing further.

THE COURT: All right. You may step down.

1 25 Thank you very much.

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Page 878

DIRECT EXAMINATION
BY MR. MacFERRiN:
Q. Good afternoon, Dr. Manwaring.
A. Good afternoon.

Q. Would you please introduce yourself to the jury?

A. Yes. I'm Kim Manwaring.

Q. Where do you live, Mr. Manwaring?

A. Phoenix, Arizona.

Q. Are you married?

A. Yes.

Q. Do you have any children?

A. Yes.

Q. How many?

a. Three.

Q. How long have you been married?

A. 26 years. *

Q. You're a medical doctor?

A. Yes.

Q. How long have you practiced medicine?
A. Since 1982.

Q. And where is your practice?
A. In Phoenix.

Q. And where specifically do you practice?
A. Phoenix Children's Hospital.

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

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1 Q. And what is your practice?

Page 879

A. I specialize in the subspecialty of neurosurgery
called pediatric neurosurgery.
Q. Does that work include clinical and research?
A. In my position, that is correct.
Q. What kind of research do you do?
A. A variety of dissection and monitoring technologies

8 that may eventually impact diseases affecting children.

9 Q. Does that work include developing devices for use in
10 surgeries?

I J A. Yes.

12 Q. What kind of devices are those?

13 A. Techniques, actual instruments or tools used in the

1 4 operating rooms of neurosurgeons to facilitate the outcome.

15 Q. How often are you in the operating room?

1 6 A. I do about 300 surgical procedures a year.

17 Typically, five or six cases a week would be common.

18 Q. What kind of procedures do you perform?

19 A. A variety of problems for children, include the

20 management of head trauma such as the swelling or

21 hemorrhage in the brain when a child suffers an accident
122 like falling off a bicycle or hit by a car. Tumour

23 surgery, a form of cancer within the brain or spinal cord.

24 Malformations of the spinal cord or nervous system such
[25 as spina bifida, reconstruction surgeries of the head and

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Page 881

instruments that allow the dissection or focusing or
coagulation or actual removal of tissue through that spot
and hence the term micro, because it's through an
endoscope where they're magnifying and it's very tiny to
operate, typically on the range of, oh, a 1 6th of an inch,
an 8th of an inch area.

Q- That is because you are operating on children?

A. No, these principles also apply to adult

neurosurgery. And I do do adult neurosurgery occasionally

when it applies to my specialty.

Q. Do you have any patents or publications in the field

of electrosurgery?

A. Yes.

Q. Roughly, how many?

A. I have two patents in electrosurgery.

Q. And roughly how many publications do you have?

A. Several. I'd have to look at my curriculum vitae or

CV to count them.

Q. What is a curriculum vitae?

A. It's a summary or listing of my publications,

presentations, patents, funding I've received to do

research.

Q. Gould you turn please to Tab DTX-427 in your binder?
A. Yes.

Q. Can you identify that for us?

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Page 880

1 face when it's malformed.

2 Q. Do you use - what kind of devices do you use to
perform those procedures?

A. The instruments commonly consist of dissectors or
knives, forms of tweezers or forceps. Neurosurgery
contains a number of very specialized instruments because
of the constraints or limitations of working on the brain.

8 Q. Do you use any electrosurgical devices in your

9 practice?
JlO A. Yes.

111 Q. And what kind of devices are those?

1 12 A. Monopolar and bipolar electrode surgery is common or

113 main stage neurosurgery.
|I4 Q. Do you use any devices that you developed?

15 A. Yes.

16 Q. What device is that?

117 A. A common device I use is called the Cogman ME2,
18 which is a contraption used as an micro endoscopic
(19 dissector.

20 Q. When you say that, in other words, what is a
|21 microscopic dissector?

J22 A. When we enter into the brain through a small
23 incision, we can actually pass an endoscope deep into a
124 target with minimal injury to the brain. When we're
|25 visualizing that target within the brain, we use

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Page 882

A. Yes. This is my curriculum vitae.
Q. Is that like a resume?
A. Yes.

Q. Is this an accurate description of your curriculum
vitae as of the time it was updated in October of 2002?
A. Yes.

MR. MacFERJUN: Your Honor, I ask this exhibit,
DTX-427, be admitted into evidence.

MR. BOBROW: No objection.

THE COURT: Thank you.

THE DEPUTY CLERK: So marked.
*** (Defendant's Exhibit No. 427 was received into
evidence.)

BY MR. MacFERJUN:

Q. Have you received any awards for your work?
A. Yes.

Q. More than one? 4
A. I'm sorry?

Q. Have you received more than one?
A. Yes.

Q. Now, I'd like to ask specifically about this case.
How did you first become involved in this case?
A. About one year ago, you, Mr. MacFerrin contacted me
asking me if I would be willing to review the patent in
question as it related to certain claims.

ArthroCarc v. Smith & Nephew, CA No. 01-504 (SLR)

Page 879 - Page 882

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Page 883

Q. Are you being compensated for your time working on
this case?
A. Yes.

Q. What were you asked to do?
A. I was asked to read through and compare also to my
patent, and render a judgment whether I felt those claims
were valid.

Q. Could you turn please to JTX-2, the binder in front
of you?

A. (Witness complied.)
Q. What is this?

A. Yes. This is the patent you asked me to review. It
is authored by Mr. Eggers and it is referred to subsequently
as the '882 patent.

Q. What work did you do for your review of this patent?
A. I read through this patent as well as some additional
materials, including my patent, and reviewed in discussion

1 8 with you principally by telephone at a distance my

19 reactions to it
Q- Other than your patent, were there any other
materials that you reviewed?

A. Yes. I was subsequently given additional materials
that included the opinion of Dr. Goldberg.
Q. Did you form an opinion on whether or not the '882
patent claims are valid?

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Page 885

25

is called a tissue vaporizing accessory and method for
an endoscope.

Q. Are you familiar with the term monopolar?
A. Yes,

Q. Did you read Mr. Eggers' testimony about the '882

patent?

A. Yes.

Q. Did you read the part where he discusses Claim 1 of
his patent includes monopolar?

A. That can employ and work with a monopolar approach,
that's correct.

Q. What kind of device is your device?
A. My device is monopolar.

MR. MacFERRiN: Your Honor, I move that dtx-46
be admitted into evidence.

THE COURT: And actually it shouldn't have been
on the screen until it was admitted into evidence.

Is there any objection?

MR. BOBROW: No objection.

THE COURT: All right. Thank you.

MR. MacFERRTN: I apologize.

THE COURT: That's all right,
BY MR. MacFERRTN:

Q. Did the device described by this patent ever become a
product?

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Page 884

A. Yes.

Q. What is your opinion?

A. I feel that the claims and limitations are, in large
part, not valid. When I say in large part, some of them
feel are unique and valid

Q. How about Claims 13 - if 1 could direct your
attention to Claims 13 and 54 of the '882 patent..

Did you reach an opinion on the validity of
those patents?
A. Yes.

Q. What is your opinion?
A. They are not valid.

Q. I'd now like to ask you about your patent If you
could turn please to DTX-46 in your binder...

MR. MacFERRiN: Gary, could you pull this up,

please?

BY MR. MacFERRiN:

Q. Is this the 1 138 patent from which your opinion is
based?
A. Yes.

Q. Is that your name there?
A. Yes.

Q. Now, what does this patent show?
A. This is the description of a device which I

[25 developed and routinely use in the operating room. It

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Page 886

A. My patent?
Q. Yes.

A. Yes, that is a product

Q. And what is the name of that product?

A. Yes, this is the Cogman ME2 1 was referring to

earlier in one of your previous questions.

Q. Do you make or sell that product?

A. No.

Q. Does someone else make or sell that product?
A. Yes.

Q. Who is that?

A. It's marketed by the Division of Neurosurgery
within Johnson & Johnson which is called Cogman.
Q. Yd now like to turn to the basis for your opinions.
A. Okay.

Q. What is the basis for your opinion that Claims 13
and 54 of the '882 patent are invalid in view of your
patent?

A. I feel my patent describes each of the those
entities when read carefully matched component to
component

Q. I'd now like to ask you how did you that analysis.

MR. MacFERRiN: Gary, could you please put up
DTX-201?

ArthroCare v. Smith & Nephew, CA No. 01-504 (SMJt\

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Page 887

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DY MR. MacFERRIN:

Q. If I could correct your attention to this slide.
Could you tell us what this is showing us?
A. The pictogram on the right is derived directly from
my patent on the front page and shows the tip of my
vaporizing accessory.

On the left, in the left column under Claim 1
of '882 is the word description or first claim of Mr.
Eggers' patent.

Q. Would it help you to have a laser pointer to use?
A. I suppose.

MR. MacFERRIN; Your Honor, may I approach?

14 THE COURT: Yes, you may.

15 BY MR. MacFERRIN:

16 Q. Before I ask you about this, I just want to make sure

17 that I was clear about one thing about Mr. Eggers'

18 testimony you read. His testimony about monopolar, that

19 did not concern your patent, did it?

20 A. Not that I understand, no.

21 Q. Did that concern his patent, the '882 patent?

22 A. Yes.

23 Q. Does your patent disclose the first part of Claim 1

24 shown here, method for applying energy to a target site

25 on a patient body structure?

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Tuesday, May 6 > 2003
Page 889

please?

This is DD'OC -- actually DDTX-202. could I have
DDTX-202 please?

Okay.
BY MR. MacFERRIN:

Q. Well, let me ask you, about - sorry.

(Pause.)
BY MR. MacFERRIN:

Q. Here we go. It looks like it's a little out of
order. I apologize. This is DDTX-204. And I'd like to
ask you about - do you see that? What is this graphic
showing us?

A. Well, again, this is my same picture on the front of
my patent, but the tip of it, the tip of the electrode
within the tip of the catheter itself or the device that
is passed through an endoscope is highlighted in red, and
on the left is a column extracting or highlighting
certain words of Mr. Eggers 1 patent providing an
electrode terminal, and here in my description of my
patent is essentially the identical description.
Q. Can you point out, is there an electrode terminal?
A. Yes. I'm sorry. The first end of the electrical
conductor extends coaxially through the tube.

This is the equivalent of the electrode
terminal.

Page 888

1 A. Yes. In fact, I feel Claim 1 is a very good

2 description of my patent.

3 Q. Have you read Dr. Goldberg's rebuttal report?

4 A. Yes.

5 Q. Did you read that after you had submitted your report?

6 A. No, I read it first. I'm talking about that which

7 was supplied to me about two months ago. I read his

8 report at that point but the rebuttal I've been aware of

9 subsequently; only recently read that, perhaps three days

10 ago.

11 Q. But you have read that?
A. Yes.

Q. And in his report, in that rebuttal report, does he
disagree with you that is patent discloses limitations?
A- Yes. Oh, I'm sorry. I misunderstood you. His
disagrees about limitations and my interpretation, but he
does not disagree with this Claim 1 that also describes
8 my patent

Did I understand you correctly?
Q. I think you did.

A. Okay. Could you talk just a little louder?
Q. Okay. Sorry.
A. Thank you.
24 Q. I'm getting over a cold.

MR. MacFERRIN: Could I have the next graphic,

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Page 890

MR. MacFERRIN: May I have DDTX-202?
BY MR. MacFERRIN:

Q. And what is this graphic showing us?
A. Again, the same picture, and again, wording from
Claim 1 from Mr. Eggers 1 and wording from my patent.
Here, we're describing the necessity to have this device
function correctly is that of a return electrode which is
electrically coupled to a high-frequency voltage source.

In my description, in accordance with standard
practice, the RF generator, radio frequency generator, is
grounded to the patient on whom surgery is to be performed.
Q. And in his report, does Dr. Goldberg disagree with
your conclusion that your patent discloses this feature?
A. No.

Q. Did lie disagree with the previously-featured
electrode terminal that which was disclosed in your
patent? <
A. No.

MR. MacFERRIN: Can I have the next graphic,

please?

BY MR. MacFERRIN:

Q. Would you please explain to us what this graphic is
showing?

A, In the '882 patent of Mr. Eggers, highlighted terms
are, relate more to the method or technique of use now

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Page 891

that the electrode terminal is positioned in close
proximity to the target site in the presence of an
electrically conducting fluid.

Then derived from my patent, as illustrated
in Figures 2 and 4, a source of pressurized fluid such as
electrically conductive saline can be injected into the
second input of the Tuohy-Borst adaptors. This is how
my device is hooked up. These are merely connectors.

Q. In his report, does Dr. Goldberg disagree that your
10 patent discloses this feature?
Ill A. No.

MR. MacFERRlN: For the record, this is
DQTX-204.

Could I next have - actually, yes, can I next
have DDTX-205? DDTX-206.
(Pause.)

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Page 893

fluid is conductive of electricity.

So as current heat passes through it, it heats
the fluid in the tiny recessed tip area. That creates a
steam barrier. And now the electricity passes across by
sparking or arcing, which is an essential component for
my device to work.

Q. You mentioned steam. Does that have an appearance?
Do you see bubbles?

A. Yes. In operation, one does visualize bubbles.
Q. And the spark or arc that you described, does that
have - can you describe that appearance for us?
A. Yes. It has a kind of yellow-orange glow.

MR. MacFERRlN: if I can have DDTX-206.-
BY MR MacFERRlN:

Q. Dr. Manwaring, could you describe what we are seeing
here? *
A. Yes. In Claim 13 now of Mr. Eggers* patent, the
method of Claim 1 wherein at least a portion of the energy
induced is in the form of photons having a wavelength in
the ultraviolet spectrum.

Then in my patent, such RF sparking is
22 generally referred to as figuration and is a well-known
[23 phenomenon.

Q. Does that sparking result in ultraviolet light?

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Page 892

BY MR MacFERRlN:

Q. Dr. Manwaring, what is this graphic?
A. This is, again, that same format In Mr. Gregor's
patent he explains it is necessary to apply a high-

6 frequency voltage between the electrode terminal and the

7 return electrode. The high-frequency voltage being

8 sufficient to vaporize the fluid in a thin layer over at

9 least a portion of the electrode terminal.

JlO Li my device, I describe the exact same

11 concept. The adjacent tissue is rapidly dessicated and

12 then vaporized Such RF sparking followed by fluid

13 vaporization is generally referred to as figuration and
1 1 4 is a well-known phenomenon.

15 I should explain* in my picture, fluid-filled

16 medium, the tip of this electrode is placed in salt-laden
117 fluid. In the instance of the brain, that as

18 cerebrospinal fluid. In the instance of other targets, it

19 is very similar fluid, call physiologic saline, and acts

20 the same from an RF or electrosurgery point

21 Q. That spark that you described, what does that
|22 reflect?

23 A. Off of the tip of the electrode emits a spark. Since

24 there is salt fluid in the tip of that environment, as RF .
1 25 or electricity is passed down through that tip, the salt

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

A. I am sure it does.

Page 894

Q. Why are you sure that it does?

MR. bobrow: object, your Honor. Uiat is
beyond the scope of his report.

THE COURT: Overruled. The specific matter
that we discussed cannot be admitted. If there is another
basis for that opinion, that doesn't involve the matter we
discussed, then I will allow the question.

MR. MacFERRlN: Thank you, your Honor.
9 THE WITNESS: 1 can answer?

1 0 BY MR- MacFERRlN:

11 Q. Yes.

12 A. When an electrode is put into salt water, whether

13 it is a monopolar pencil blade or my electrode or Mr.

1 4 Eggers' electrode, if it is in salt water and electricity

15 is passing through it with sufficient intensity to create

16 sparking, that sparking emits light And some of that

17 light is perceivable by the eye, which is the orange/ 4

18 yellow glow I described, but some of it is not perceivable

19 by die eye, which is outside of that range.

20 Q. Can you think of any other examples of something you

21 can't see, but you know it's there?

22 A. Sure. In the instance of light, since we are

23 talking about light, most of us are familiar with the

24 famous scientist Isaac Newton. Isaac Newton held up a

25 prism in the sunlight and, as the sunlight passed through

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the prism, he saw on the back wall a whole display of
colors, which we now refer to as a rainbow, because the
exact same thing happens in the sky as sunlight passes
through moisture.

And that rainbow includes colors that we are
all familiar with, tapering out at both ends to no other
colors.

But Isaac Newton found that there were other
colors in that light spectrum that couldn't be seen with
the eye. In fact, he is the one who gave us the term
infrared, which means below red, because he discerned that
there was heat being emitted in the prism beyond where
there was no light.

So infrared is an example of light you can't

1 15 see but you can feel. The other end of the spectrum is

1 1 6 ultraviolet, which is also there, but we can 1 1 see it with
our eyes. We know it's there.

MR. MacFERRTN: May I have the next one,

J 19 please?

20 BY MR. MacFERRTN:

21 Q. DDTX-207. Dr. Manwaring, could you describe for us

22 what this graphic is showing?

23 A. Yes. Again, in Mr. Gregor's patent is a Claim No. 54,

24 which also derives from Claim 1 . It describes a method
[25 with a device further comprising evacuating fluid generated

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Page 89 .

CROSS-EXAMINATION
BY MR. BOBROW:

Q. Good afternoon, Dr. Manwaring.
A. Good afternoon.

Q. We met briefly in the hallway. My name is Jared
Bobrow. I am one of the attorneys representing ArthroCare
Corporation.

First of all, you still have your patent, the
'138 patent; is that right?
A. Yes.

Q. And if I understood what you just testified to about
ultraviolet photons, it's your testimony that where you
refer in this patent to sparking, that that is a
disclosure of the emission of ultraviolet photons; is that
right?

A. The emission of all light that arises from that
process. '
Q. Does that include ultraviolet photons?
A. Sure.

Q. Now, your patent never refers to ultraviolet photons,
does it?
A. No.

Q. There is no mention in it, in fact, of ultraviolet
light; is that correct?

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Page 896

at the target site with a suction lumen having a distal end
adjacent to the electrode terminal.

And in my patent, the similar wording, again.
Again, this tip is in that fluid environment. In such
an alternative embodiment of the invention, a neutral or
negative pressure could be provided within the fluid
interior of Tube 28 such that the fluid from the fluid-

8 filled medium of the working environment could be sucked

9 or drawn up to a sufficient elevation.

10 Q. So does your patent disclose this additional feature

11 pfaaim54?

12 A. Yes.

13 Q. If I could ask you now to turn to DTX-46 in your

14 binder...

15 Dr. Manwaring, do you understand your patent -

16 what date did your patent issue?

17 A. June 16, 1992, my patent was issued.

18 Q. And looking at Item 22 on the left, do you see that

19 there, Dr. Manwaring?

20 A. Yes.

|21 Q. What date was the application for your patent filed?
A. November 28, 1990.

MR. MacFERRTN: Thank you.
THE COURT: cross-examination.

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Page 898

A. That's correct

Q. And at the time that you prepared your report in
this matter back in February of this year, you hadn't
done any tests to determine whether the device that is
described in your 1 1 38 patent emits photons of
ultraviolet light Is that true?
A. That's correct

Q. Now , its also true, is it not, that back at the time
of your report, back in February, you were not aware of
anybody else doing any testing on your device that is
described here in the '138 patent to show that it emits
ultraviolet photons; correct?
A. At that time, that's correct
Q. You are not a physicist Is that true?
A. No, I am not a physicist.

Q. You do not have a degree in physics; is that right?
A. That's correct * .

Q. You do not have a degree in electrical engineering.
Is that true?
A. That's correct

Q. Now, with respect to your testimony, you mentioned
something about Isaac Newton; right?
A. Yes.

Q. And you mentioned that he detected that there was
infrared light beyond the visible portion of the rainbow.

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True?

A. That's correct.

Q. It sounds like he did some sort of a test; is that
right?

A. Yes. He held a prism into the sun.
Q. And he was able to then detect heat beyond the area;
correct?
A. Yes.

Q. And so he detected this empirically; is that right?
A. That's fair to say.
Ill Q. And at the time that you prepared your report, you

12 did nothing empirically to deterrnine that UV photons are

1 3 emitted by the device that is described in your patent,

14 the '138 patent. Is that true?
115 A. Yes. At that time I had not

Q. Now, your device that you describe in here is a
monopolar device; correct?
A. Correct.

Q. And that means that the return electrode is attached
120 someplace to the outside of the patient's body, correct?

21 A. Yes.

22 Q, And oftentimes that's attached to the thigh or the
123 back or what-have-ybu. True?
24 A. Correct

|2S Q. So when you mention that there was electrically

Tuesday, May 6, 2003

Page 900

1 conducting fluid in the brain, for example, I take it that

2 the return electrode in your invention is not in contact

3 in any way with that electrically conductive fluid. Is

4 that true?

5 A. Yes. In the sense that it's attached to trie outside

6 of the body and one is working on the inside, I believe

7 that's a fair characterization.

8 Q. So the return electrode in your invention doesn't

9 contact the electrically conductive fluid; is that right?

0 A. That's correct

1 Q. Now, you also, I believe, talked about on your
J 12 direct examination this issue of suction.

MR. BOBROW: Perhaps we can put Figure 5 of the
'138 patent up on the screen.

If you can blow that up, Chris, I would
appreciate it
BY MR. BOBROW:

Q. Here, Dr. Man waring, you see there it says fluid-filled
J 19 medium; is that right?
A. Yes.

Q. And what we are looking at there is the tip of this
device. Is that true?
A. That's correct.

Q. And the fluid-filled medium in the case of surgery
|25 on the br ain is that cerebrospinal fluid; right?
ArthroCare v. Smith & Nephew. CA No. 01-504 fSM

Page 901

1 A. No, not necessarily. Just like arthroscopic

2 surgery, we must maintain a certain amount of brain

3 enlargement because we have entered in with a trochar.

4 And, therefore, we inject fluid, which. is compatible or

5 like cerebrospinal fluid, which happens to be physiologic

6 saline or something very similar to it.

7 Q. But in your - let me ask a different question.

8 The brain is surrounded by cerebrospinal fluid; is that

9 right?

10 A. Yes.

1 1 Q. In fact, the body generates its on cerebrospinal

12 fluid; is that right?

13 A. Yes.

J 4 Q. About how much a day?

15 A. About 700 milliliters. That would be a typical -

16 that is almost a quart for your reference. Most adults

17 would make about that much a day.

1 8 Q. And the brain is surrounded by that, such when you

19 go into the surgical site there is cerebrospinal fluid

20 that is present; correct?

21 A. Yes.

22 Q. And in your patent, there is one embc<uinent where

23 you talk about introducing some saline through that tube;

24 right?

25 A. Yes.

Page 902

1 Q: And the rate at which the saline is introduced is

2 at the rate of a couple of drops a second; right?

3 A. Yes.

4 Q. About three or four drops per second. True?

5 A. You could perhaps show me where you are referring.

6 Q. That is Column 7, if you would like to look. Column 7,

7 about Line 10.

8 A. But for your purposes, I have no concern about that

9 Q. Now, if we could go to Column 7 of the patent, please.

0 The paragraph that begins at Line 1 1 and goes to Line 31.

1 MR. BOBROW: if you could please highlight

2 that...

3 BY MR. BOBROW:

4 Q. Dr. Manwaring, here in your patent you are describing

1 5 an embodiment in which you are not delivering fluid to the

1 6 surgical site; is that right?

17 A. Yes.

18 Q. In fact, at Lines 19 through 21, it begins by saying,

19 If the source of pressurized fluid as illustrated in

20 Figure 2 were omitted, some alternative means would have

21 to be provided to fill at least the interior tip of 32

22 with fluid to enable the invention to operate in the

23 fulguration mode as described above, and it goes on.

Do you see what I am referring to there?
A. Yes, I do.

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Q. So in that column, in describing this section, there
is no electrically conductive fluid being introduced into
the surgical site; correct?

A. In that the instrument is introduced into the fluid
medium, it exists there and this is what is referenced to
before as the neutral environment, in contrast to a
sucking environment, which would be negative or a positive

8 environment where one was irrigating forward.

9 Q. Just to be clear here, what you are describing in

1 10 the paragraph that is up on the screen is an embodiment
1 1 where fluid is not being introduced into the brain cavity?
112 A. Yes, that's correct.

13 Q. Okay. Now, what you are describing here, then, is

1 14 using either neutral or some sort of negative pressure to

1 1 5 suck up some of the fluid that is in the brain already;

16 correct?

17 A. That's correct

Il8 Q. That would be the cerebrospinal fluid; right?
|19 A. No. In the practical application, we always have

20 mixed salt water, or physiologic saline which has been
pi introduced by the endoscope for the exact same reasons we

22 do in arthroscopic surgery, it is to clear blood, maintain

123 that crystal -clear environment. So in appropriate

1 24 description, it is a mix:

|25 Q. Fair enough. And when the energy is applied using

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Page 904

1 your device, in this embodiment you are describing here,

2 the application of the energy isn't creating electrically
conductive fluid, is it?
A. No. It's not creating — that electrically
conductive fluid is there at the tip.
Q. And the application of energy is not what is

7 generating either cerebrospinal fluid or saline or any

8 other fluid True?

9 A. Correct.
jlO Q. Now, when you put either neutral or negative

11 pressure at the tip, isn't it fair to say that then some
1 12 fluid gets sucked in at the tip of the device; correct?
I J 3 A. In the instance —

14 Q. So it goes -

115 A. In the instance of the neutral environment, the tip

1 16 is barely recessed It is a non-contact technique. So
J 17 when the device is put into that space, fluid wells into
jlS it readily.

119 Q. Wells up into the tube of this device?
20 A. That's right.

|21 Q. And then the device is then placed in the vicinity
1 22 of the target tissue that you want to treat; correct?
[23 A. Exactly.

|24 Q. So isn't it fair to say, then, that if fluid remains
|25 at or on die target site, that you are trying to treat in

Page 905

1 the course of a surgery?

2 A. That's correct.

3 Q. Now, let's take a look at Claim I of the '882 patent,

4 which is JTJC-2.

5 MR. BOBROW: if you can go to the last Page of

6 JTX-2...

7 BY MR. BOBROW:

8 Q. Do you have that in your binder, sir?

9 A. I can bring it up, yes.

10 MR. BOBROW: if you would please, Chris,

1 1 highlight the last paragraph, that begins applying a high-

1 2 frequency voltage.

13 BY MR. BOBROW:

14 Q. Dr. Manwaring, in this paragraph, I just want to

15 make sure that I have down here the sequence at least as

16 you understand it of events that are being described here,

17 The first thing that happens is that a high-frequency

1 8 voltage is being applied between the active electrode and

19 the neutral, or return electrode. Is that true?

20 A. Yes. The return electrode.

21 Q. And by virtue of the application of that voltage,

22 then, the next thing that happens is that you vaporize

23 some fluid that is in the vicinity of the very tip of the

24 active electrode; right?

25 A. I agree.

Page 906

1 Q. And then once you form that vapor area in the tip

2 of the electrode, then what happens is you get this energy

3 discharge, either, you know, plasma or arcs or what-have-

4 you at the tip of the device, sparks, for example?

5 A. You have used sparking, yes.

6 Q. Essentially what is described here in the '882 patent

7 is application of a voltage followed by a vaporization of

8 the electrically conductive fluid, followed by sparking;

9 is that right?

10 A. I agree. .

11 Q. Now, your patent describes something different,

12 doesn't it?

13 A. No.

14 Q. Well, let's take a look and see. Let's take a look

1 5 at Column 6 of your patent. Specifically, the paragraph

16 beginning at Lines 50 through 63?

17 MR. BOBROW: if you could highlight that, *

18 Chris, I would appreciate it.

19 BY MR. BOBROW:

20 Q. Now, this is a paragraph that you had up earlier

21 when you were being asked questions on direct examination;

22 correct? Is that right?

23 A. Yes, that's correct

24 Q. And when you had this paragraph up, you were saying

25 that this language described the paragraph that we were

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1 just looking at in the *882 patent; correct?

2 A. Yes.

Q- And here, in your patent, in the 1 138 patent, it
refers in this patent, beginning at about Line 54, it
says, when end phase 40 is placed either in close proximity
to or in contact with tissue, as illustrated in Figure 5,
the sparking results in the generation of extremely high

8 temperatures, causing vaporization of the fluid within

9 region 46 and virtually instantly achieves temperatures
J 10 estimated to reach approximately 400 degrees Centigrade.

11 Then it goes on a little further down: Such RF sparking

1 2 followed by fluid vaporization is generally referred to
113 as fulguration and is well known.

1 4 Your patent, sir, is describing sparking

J 1 5 followed by fluid vaporization; correct?
16 A. Yes. Similarly, I could play with the words and
J 17 say when the device was placed into the field, as he says
18 here, the sparking emits. But it's clearly indicated in

1 19 the context that the device was actuated It is also

120 clearly indicated that you cannot get sparking in a fluid
21 medium, because there is nothing to spark across. So it

122 has to be heated.

|23 Q. Thank you. The thing is, I don't want to play with
24 the words. I am asking you that the words in your patent,
|25 which has been asserted as prior art, shows in sequence

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Page 909

A. That's correct.

Q. 1 would like to show you what was marked as DTX-424.
I apologize, sir. I don't believe that's going to be in
your binder.

DTX-424 appears to be a copy of the report
that you prepared; is that right?
A. This is correct.

8 Q. I would like to ask you about a portion of this

9 report, and specifically, on the fourth page, there is a

10 book labeled Claim 13 of the *882 patent.

1 1 Do you see that?

12 A. Yes.

13 Q. And this was language that you prepared in connection

14 with this case?

15 A. I explained my interpretations. Mr. MacFerrin

16 prepared this document. I reviewed and agreed that it was

17 consistent with. So, yes, that's reasonable to state that.

18 Q. So Mr. MacFerrin, Smith & Nephew's lawyers, prepared

19 this document, you reviewed it and then signed it after

20 comment with him?

21 A. Yes, again emphasizing, I explained my opinion. He

22 put it in paper. I reviewed it and affirmed that it was

23 consistent with.

24 MR. BOBROW: I would like to put up Claim 13

25 of Page 4 of DTX-424.

Page 908

1 sparking followed by the vaporization. Is that true?

2 A. Yes. And I want to be clear that the concept of
fulguration is a very well-known old phenomenon, which
means that sparking must jump from an electrode across to
another surface. And it implies that that order is well
known.

Q. Now, you had mentioned on your direct examination

8 that you are being compensated in connection with your

9 work on this matter?
110 A. Yes.

Smith & Nephew is the one that is paying you?
Yes.

That is at the rate of $450 an hour, is that right?
Yes.

Now, have you worked with a man by the name of Dr.

1 16 Taylor in this case?

117 A. I have not worked with him. I have met him.

1 18 Q. In connection with the preparation of your expert

1 19 report in this matter, did you consult with him?
20 A. No.

|21 Q. Did you work with him?
22 A. No.

1 23 Q. Did you two exchange drafts?
|24 A. No.

|25 Q. The two of you worked independently. That true?

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1 12 A.
|13 Q.
114 A.
[15 Q.

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Page 910

MR. BOBROW: if you could highlight that,

please...

BY MR. BOBROW:

Q. And for Claim 13, this relates to the UV photon issue;

correct?

A. Yes.

Q. And you state that the '138 patent specifically
mentions sparking during operation. Then you cite to
Column 6, Lines 50 to 63; is that right?
A. Yes.

Q. Then you say, the spark results in the emission of
UV and other wavelengths of light; correct?
A. Yes.

Q. And you signed this report; right?
A. Yes.

Q. With that language?

A. Yes. *
MR. BOBROW: Your Honor, may I approach?
THE COURT: Yes.

BY MR. BOBROW:

Q. I would like to show you now dtx-400. DTX-400 is
called Expert Report, Kenneth D. Taylor. Have you ever
seen DTX-400 before?
A. No.

Q. This is the first time?

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1 A. Yes.

2 Q. If you could, please, turn in that document to the

3 section on Claim 13. And specifically on Page 62.

4 mr. MacFERRlN: Your Honor, I object. This

5 exhibit has not been admitted into evidence.

6 THE COURT: I don't want the whole exhibit

7 admitted into evidence. It is impeachment. I am not

8 exactly sure where we are headed. Since it's lunchtime,

9 we will talk about it in a moment.

1 1 0 Members of the jury, I will remind you during

1 1 your lunch break you are not to discuss the case among
|12 yourselves or with anyone else.

13 (At this point the jury then left the

14 courtroom, and the following occurred without the presence

15 of the jury.)

1 6 THE COURT: sir, you may step down.

1 7 (Witness steps down from stand.)

18 MR. BOBROW: Your Honor, perhaps an instruction

19 should be given to the witness, in case he is unfamiliar

120 with the rules of our discussions.

121 THE COURT: All right. Hopefully the instruction

122 doesn't have to be given. I will remind counsel for the

123 defendant that he is not to discuss substantively the

|24 witness' testimony, since he is on cross. But you may go
[25 ahead and start your lunch break, since it will not be

Page 913

1 the one up, we are not going to put either that up or

2 the other one up.

3 Thank you, counsel.

4 (Luncheon recess taken.)
5

6 AFTERNOON SESSION

7

8 (Proceedings resumed at 1 :30 p.m.)

9

10 THE COURT: All right. Thank you. Anything

1 1 before we bring the jury in?

12 All right.

1 3 (At this point the jury entered the courtroom

14 and took their seats in the box.)

15 THE COURT: All right. Mr. Bobrow.

16 MR. BOBROW: Thank you, your Honor.

17 BY MR. BOBROW: .

18 Q. Good afternoon, Dr. Manwaring.

19 A. Good afternoon.

20 Q. Before the break, I was asking you about Claim 13

21 of the '882 patent, your report on the subject and Dr.

22 Taylor's report on the subject.

23 Are you with me so far?

24 A. Yes.

25 Q. Now, do you still have your report in front of you?

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1 very quick.

With respect to this, of course, anything can
be used to impeach an expert, even a rock. Generally,
it's real difficult because I generally don't allow
documents to be shown to a jury that haven't been admitted.
But I certainly don't want to admit expert reports.

So the question is whether any of this should

8 be shown to the jury as opposed to your directing the

9 examination without the illustration. That's basically
10 the objection at this point?

MR. MacFERRlN: it is, your Honor.

12 MR. BOBROW: Your Honor, I think it is fair

13 for the jury to see side by side the language that

14 two experts put together independently, they will testify

15 that it's the same language. I think 1 am entitled to

16 impeach on that basis.

17 the COURT: Don't use that word.
MR. MacFERRlN: Your Honor, if I may respond.

19 These exhibits are never going to come into evidence.

20 They are expert reports. Earlier, a 510-K was used for
[21 impeachment. And that was not permitted to be shown to
22 the jury.

1 23 THE COURT: That's true. So we have to play

24 by the same rules.

125 All right Despite the fact we let you put

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A. On Page 62?

Q. Your report, which is DTX-424, Page 4.
A. Yes, I do.

Q. And when you were commenting in your report on the
* 138 patent and its relationship to Claim 13, you wrote,
quote, The '138 patent specifically mentions sparking
during operation, period. Column 6, Lines 50-63, period
The spark results in the emission of UV and other
wavelengths of light; correct?
A. Yes, rrmi-hmm.

Q. Now, if you can turn, please, to DTX-400«

And this is Dr. Taylor's report; correct?
A. Yes.

Q. This is the report that you have never seen before;
right?

A. That's correct.

Q. And turn to Page 62, please. *
A. I'm there.

Q. And you see in the middle of the page, there is a
discussion about Claim 13. Do you see that?
A. Yes.

Q. And this is about the '882 patent; right?
A That, I don't know, but it surely looks familiar.
Q. Yes. And you will see that in Dr. Taylor's report
it is written, quote, Manwaring '138 specifically mentions

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sparking during operation, period. Column 6, Lines 50-63
period. The spark results in the emission of uv and
other wavelengths of light.

Do you see what I'm referring to there?
A. Yes, 1 do.

Q. The language in your report and the language in Dr.
Taylor's report is identical, even down to the punctuation?
A. Okay.

Q Except Dr. Taylor says Man waring • 138 and you say
the '138 patent; correct?
A. Okay.
Q. Is that true?
A. Yes, it looks like it to me.
Q. Now, take a look, please, if you would, at Page 5,
running over to 6 of your report. This deals with Claim
54 of the '882 patent

Do you have that, sir?
A. I do.

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1 19 Q. And you will see there that in discussing Claim 54

120 of ArthroCare '882 patent you wrote, quote, The f 138
21 patent discloses a evacuating fluid generated at the

122 target site using a suction lumen with a distal end

23 adjacent the electrode terminal, period. Column 7, Lines

24 26 to 31?

25 A. Yes.

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REDIRECT EXAMINATION
BY MR. MacFERRIN:

Q. Dr. Manwaring, Til try to speak louder this time.

Do you have any education or training in
physics?
A. Yes.

Q. How about electrical engineering?
A. Yes.

Q. Did you take courses in college on those subjects?
A. Yes.

Q. In that college course on physics, did you cover
the experiment that you described that Newton had before
him?
A. Yes.

Q. Is that basic physics?
A. Yes.

Q. Do you use physics and electrical engineering
principles in your research?
A. Routinely.

Q. Now, when you signed your report, why didn't you
test for uv protons?

A. For the very simple reason that I hadn't been asked

24 to. I was given a charge to review and render an opinion

25 and I became very curious about whether there was

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Page 916

Q. That's in your report; right?
A. Yes.

Q. Now, take a look at Dr. Taylor's report. And if you
could turn to Page 81...

And at the top of the page, there is a
discussion of Claim 54. Do you see that?
A. Yes, I do.

8 Q. And there is a reference there to the Manwaring

9 '138 patent Do you see that as well?
1 10 A. I do

11 Q. And in discussing Claim 54, Dr. Taylor's report

12 states, quote, Manwaring '138 discloses a evacuating fluid

13 generated at the target site, using a suction lumen with a

114 distal end adjacent the electrode terminal, period

115 Column 7, Lines 26 to 31.
|16 Do you see what I'm referring to?

17 A. Yes, I do

118 Q. And that language is word for word, coma for coma,
Jl9 the same words as what is your report except you say the
120 ' 1 38 patent and he says the Manwaring '138 patent; right?
|21 A. Looks like that
22 Q. Okay.

1 23 MR. BOBROW: Thank you, sir

|24
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Page 918

something unique about their instrument, and the more I
read into how the spark was being made and could see the
pictures of documents, I concluded that is identical to
how I do it, and so I have been provoked to look at that
further, since our discussions.
Q. Well, before we -

MR. BOBROW: Your Honor?

BY MR. MacFERRIN:

Q. So was there no need or did you feel there was any

need for to you do any testing?

A. No, nothing was brought to my attention.

MR. MacFERRIN: Now, your Honor, I believe Dr.
Manwaring was asked about tests on cross-examination. I
believe that opened the door to the other matter that was
excluded.

THE COURT: No, it did not

MR. MacFERRIN: Okay. *
BY MR. MacFERRIN:

Q- Now, turning to the discussion of the Taylor report,
where he says that the spark results in uv protons, the
spark in your patent, does it surprise you that he agrees
with you?

A. Well, I would be surprised if he didn't. If someone
is skilled in the art of RF, I think if you looked at the
mechanism of how the energy was being passed through a

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

Page 915 -Page 918

Jury Trial - Volume E

1 salt-laden water, I would be surprised if it isn't

2 identical among all these devices that are used in that

3 environment.

4 MR. MacFERRIN: Could I please have JTX-2?

5 BY MR. MacFERRIN:

6 Q. Could you please turn to JTX-2 in your binder, Dr.

7 Manwaring, in the last page?

MR. MacFERRIN: And could I have that up on
the screen?
BY MR. MacFERRIN:
Q. What does this show?

Condcnselt™

Page

12 A.

Tuesday, May 6, 2002

Page 921

1 That's the principle.

2 Q. Do you consider that evacuation?

3 A. Yes.

4 Q. Now, the fluid that is evacuated, would that include

5 fluid that was generated at the target site?

6 A. It can.

7 Q. What kind of fluid would that include?

8 A. Well, heating in the presence of biologic tissue.

9 Let's say one is ablating, which means removing, tumor
0 tissue in the brain. That tissue is vaporized. And in

that vaporization is fluid in the form of gas, which

13 refers to Claim No. 1 of the Eggers patent. And being a J3 normal saline. So it's a mix again

m 14 Q. Could you now tun,, please, to Column 6, Lines 50 to

15 has ibeen made and approved in the language of the first 15 63? .^nesDuto

16 claim.

17 Q. Td like to ask you, Dr. Manwaring, you were asked

18 about the rate of saline in your patent. Does this claim

19 say anything about the rate of saline delivery?
120 A. No.

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1 1 6 MR. MacFERRIN: Chris, if you could pull that

17 up for me, I would appreciate it.

18 BY MR. MacFERRIN:

19 Q. Now, are you referring to fulguration in this
1 20 passage?

21 A. That's correct. Maybe I could define fulguration,

22 because I know it's an unusual term.

[23 Q. I would appreciate it if you would explain to the
[24 jury what the sequence of events in fulguration is? -
[25 A. Yes. In surgery, when we use electrosurgery, we

Page 920

Q. Does the rate of saline delivery have anything to do
with the validity of this claim?
A. No, not whatsoever.

Q. If I could ask you to turn now to your patent,
DTX-46.„

MR, MacFERRIN: if I can have that up on the
8 screen, please...
BY MR. MacFERRIN:
110 Q. I would like to ask you in particular to direct your
11 attention Column 7, Lines 26 to 31. I believe you were
J 12 asked about this on cross-examination. Do you see that
113 there?
14 A. Yes, I do.

1 15 Q. Now, the fluid that is, does it say the negative

1 16 pressure will drop fluid up into the tube?
17 A. Yes.

1 1 8 Q. Would that remove that fluid from the target site?

119 A. No. It's important to emphasize that the fluid

20 must always be present at the active electrode.

21 Q. Would there be some fluid that was removed from the
122 target site?

23 A. Yes. Fluid would always be there, and the evacuation,
124 whether it is sucking, essentially pulls fluid which is
|25 salt laden, electrically conductive, by the electrode.

Page 922

1 can cut, we can coagulate or desiccate, or we can

2 fulgurate. That is essentially all we can do. When we

3 cut, we use one waveform and one voltage that incises

4 tissue and it has some heating effect, but it doesn't

5 really impart good sealing of blood vessels. So the blood

6 vessels can bleed, just like if you cut with a cold blade.

7 It's a litde better than that

8 When we contact desiccate, we have tied that

9 electrode right to the face of the tissue and it drives

10 current through the tissue. And as it goes by, it drives

11 the moisture out of the cells, and it seals blood vessels.

12 So we call it coagulation or desiccation, depending on

1 3 what technique we want

14 On the other hand, fulguration, which is the

1 5 subject of my patent, is to have an electrode stand off

16 the surface of tissue and spark down to it That sparking

17 is very high voltage, to get that effect. You can't do if

18 with low voltage or cutting. It has to be high. Typically

19 a thousand volts would be used. And that spark comes down

20 and hits the surface of the tissue and sears it, much like

21 the searing you are familiar with in cooking. And that

22 preserves the tissue beneath, keeps it viable, but stops

23 surface bleeding.

24 In this device, when we work in spinal fluid or

25 normal saline, fulguration refers to the sparking effect

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

Page 919 -Page 922

Jury Trial - Volume E

Condense! t

TM

Page 923

You don't see sparking in contact desiccation. And with
a magnifier, you might see it with cutting, but fuiguration
is truly what makes visible spark to your eye. And that
sparking is passing across the steam barrier into the
saline, or as you get closer to tissue. And that's what's
having the therapeutic effect

So it must have spark, it must have high
voltage, it must have a gap and it must have non-contact.
Q. What happens first, the arc or the steam barrier?
A. The - I will back up and explain this way.
Electricity passing through saline starts it to heat.
The heat turns into vapor. Now a spark can jump across.
Q. So, did you say you have vaporization before you

1 14 have a spark?

1 15 A. That's correct

16 Q. Do you continue to have vaporization after the spark?

17 A. Well, the vapor collapses into the tissue. As soon

18 as the heat goes away, it's not sustained. Just like

19 boiling on a pot People are familiar with that The
[20 bundle is a steam barrier.

21 Q. You were also asked about the fact that your device
|22 is monopolar?

23 A. Yes.

24 Q. Does that matter to the validity of these claims of

25 the '882 patent?

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Tuesday, May 6, 2003

Page 925

into the courtroom now is Warren Heim! He was mentioned
in Mr. Sparks' testimony. He is a mechanical engineer
who specializes in medical devices. He was engaged by
Smith & Nephew as a consultant in the development of the
Control RF product He is going to testify about that
development, as well as some analysis that he did of the
•882 patent early in that development process. The '882

8 patent is the one we have also called the multiple-

9 electrode patent

10
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... WARREN P. HEIM, having been
duly sworn as a witness, was examined
and testified as follows ...

DIRECT EXAMINATION

BY MS. BOYD:

Q. Can you please introduce yourself to the jury and

17 tell them a little about yourself?

18 A. Certainly. My name is Warren Heim. I live in

19 Boulder, Colorado. I live there with my wife. We have

20 been married for 23 years. We have four sons.

21 Q. That's quite a house you must have?

22 A. It is a busy one.
1 23 Q. What do you do for a living?
24 A. My wife and I own a small medical device research
[25 and development company. The name of the company is

Page 924

3

4

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1 A. No, not in my judgment

2 Q. Do you recall Mr. Eggers saying that that did not
that his claim included monopolar devices?
A. That's right

Q. Does that confirm your opinion, the fact that your
device is monopolar doesn't matter to the validity?
A. Yes, I know my device works in a bipolar mode, I

8 know my device works in a monopolar mode. I think that

9 is transparent to this issue of fuiguration.

10 Q. You were also asked about your rate. Is that your

11 usual rate?

12 A. No. In fact, most of the time, as you might imagine,

13 I testify on issues of medical injury, like non-accidental

14 trauma, shaken baby, very commonly neurosurgeons testify

15 typically at about $500 an hour if they were involved as

16 expert witnesses.

17 Q. Why are you charging less than your usual rate?

18 A. Well, I have a particular interest I am quite

19 curious, because my patent has been cited as prior art
MR. MacFERRiN; Thank you, Dr. Manwaring.
THE COURT: All right Thank you very much,

20
21

122 sir.
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(Witness excused)
MS. BOYD: Our next witness making his way

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Page 926

Team Medical. Team Medical develops new medical device
technology based on our internal R&D efforts, patents
the technology, and then licenses that technology to
premium quality medical device companies.
Q Does Team Medical actually sell medical devices?
A. Team Medical does not manufacture nor sell products
of its own. We are an R&D company. We have laboratories
and analytical skills that we use to develop our
technology that we then patent
Q. Can you describe for the jury your educational
background, starting with college, please?
A. I attended Dartmouth College. Dartmouth is in
Hanover, New Harripshire. I was at Dartmouth for six years
and I received three degrees from the institution. In
1 973, 1 graduated with an AB, that is a Bachelor's of
Arts degree, it was a liberal arts degree. I then went a
fifth year, and graduated with a Bachelor of Engineering
degree. I then was there another year, and graduated with
a Master's of Engineering Agree. The specialty was
mechanical engineering.

Q. Can you describe what work you did imraediately
after graduating with your Master's degree in engineering?
A. When I graduated in 1975, 1 initially worked in the
energy and environmental field. In particular, I worked
on various projects associated with converting coal and

ArthroCare v. Smith & Nephew, CA No. 01-504 (SLR)

Paee 923 - Patre 07.6